Constipation Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
| Verified date | August 2017 |
| Source | Cubist Pharmaceuticals LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.
| Status | Completed |
| Enrollment | 805 |
| Est. completion date | February 1, 2007 |
| Est. primary completion date | February 1, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Consented to participate in this study. - Taking opioid therapy for persistent non-cancer pain. - Has bowel dysfunction mainly due to opioids. - Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms. - Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed). Exclusion criteria: - Pregnant, lactating, or planning to become pregnant. - Not ambulatory. - Participated in another trial with an investigational drug in the past 30 days. - Taking opioids for the management of drug addiction or cancer-related pain. - Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation. - Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction. - Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | GSK Investigational Site | Bedford Park | South Australia |
| Australia | GSK Investigational Site | Box Hill | Victoria |
| Australia | GSK Investigational Site | Broadmeadow | New South Wales |
| Australia | GSK Investigational Site | Carina Heights | Queensland |
| Australia | GSK Investigational Site | Carlton | Victoria |
| Australia | GSK Investigational Site | Fremantle | Western Australia |
| Australia | GSK Investigational Site | Kippa Ring | Queensland |
| Australia | GSK Investigational Site | Port Lincoln | South Australia |
| Australia | GSK Investigational Site | St Leonards | New South Wales |
| Australia | GSK Investigational Site | Toorak Gardens | South Australia |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Canada | GSK Investigational Site | Bonaventure | Quebec |
| Canada | GSK Investigational Site | Brampton | Ontario |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Chandler | Quebec |
| Canada | GSK Investigational Site | Charlottetown | Prince Edward Island |
| Canada | GSK Investigational Site | Coquitlam | British Columbia |
| Canada | GSK Investigational Site | Drummondville | Quebec |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Halifax | Nova Scotia |
| Canada | GSK Investigational Site | Hamilton | Ontario |
| Canada | GSK Investigational Site | Kelowna | British Columbia |
| Canada | GSK Investigational Site | Kitchener | Ontario |
| Canada | GSK Investigational Site | Langley | British Columbia |
| Canada | GSK Investigational Site | Mirabel | Quebec |
| Canada | GSK Investigational Site | Mississauga | Ontario |
| Canada | GSK Investigational Site | Moncton | New Brunswick |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | North Bay | Ontario |
| Canada | GSK Investigational Site | North York | Ontario |
| Canada | GSK Investigational Site | Saint John's | Newfoundland and Labrador |
| Canada | GSK Investigational Site | Saint Romuald | Quebec |
| Canada | GSK Investigational Site | Sherbrooke | Quebec |
| Canada | GSK Investigational Site | Sudbury | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Trois-Rivieres | Quebec |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Denmark | GSK Investigational Site | Ishoj | |
| Finland | GSK Investigational Site | Helsinki | |
| Hong Kong | GSK Investigational Site | Kowloon | |
| Hong Kong | GSK Investigational Site | Kwun Tong | |
| Hong Kong | GSK Investigational Site | Pokfulam | |
| Hong Kong | GSK Investigational Site | Shatin | |
| Hungary | GSK Investigational Site | Budapest | |
| Ireland | GSK Investigational Site | Cork | |
| Netherlands | GSK Investigational Site | Roosendaal | |
| Netherlands | GSK Investigational Site | Utrecht | |
| New Zealand | GSK Investigational Site | Christchurch | |
| New Zealand | GSK Investigational Site | Hamilton | |
| New Zealand | GSK Investigational Site | Tauranga | |
| Poland | GSK Investigational Site | Gdansk | |
| Poland | GSK Investigational Site | Krakow | |
| Poland | GSK Investigational Site | Wroclaw | |
| Spain | GSK Investigational Site | Alcorcon | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | El Ferrol | |
| Spain | GSK Investigational Site | Granada | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Santander | |
| Spain | GSK Investigational Site | Valencia | |
| Sweden | GSK Investigational Site | Jönköping | |
| Sweden | GSK Investigational Site | Karlstad | |
| Sweden | GSK Investigational Site | Linköping | |
| Sweden | GSK Investigational Site | Stockholm | |
| Switzerland | GSK Investigational Site | Bern | |
| Taiwan | GSK Investigational Site | Tainan | |
| Taiwan | GSK Investigational Site | Taipei | |
| Taiwan | GSK Investigational Site | Taipei | |
| United Kingdom | GSK Investigational Site | Bexhill-on-Sea, East Sussex | |
| United Kingdom | GSK Investigational Site | Cardiff | Glamorgan |
| United Kingdom | GSK Investigational Site | Coventry | Warwickshire |
| United Kingdom | GSK Investigational Site | Glasgow | Lanarkshire |
| United Kingdom | GSK Investigational Site | Glasgow | Lanarkshire |
| United Kingdom | GSK Investigational Site | Leeds | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Reading | Berkshire |
| United Kingdom | GSK Investigational Site | Slough | Berkshire |
| United Kingdom | GSK Investigational Site | Sunbury-on-Thames | Middlesex |
| United Kingdom | GSK Investigational Site | Yaxley, Peterborough | |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Anaheim | California |
| United States | GSK Investigational Site | Anaheim | California |
| United States | GSK Investigational Site | Arlington | Texas |
| United States | GSK Investigational Site | Arlington Heights | Illinois |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Bakersfield | California |
| United States | GSK Investigational Site | Baton Rouge | Louisiana |
| United States | GSK Investigational Site | Bellingham | Washington |
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| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Blackwood | New Jersey |
| United States | GSK Investigational Site | Bloomington | Illinois |
| United States | GSK Investigational Site | Boise | Idaho |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Brandon | Florida |
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| United States | GSK Investigational Site | Brownwood | Texas |
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| United States | GSK Investigational Site | Carnegie | Pennsylvania |
| United States | GSK Investigational Site | Centerville | Ohio |
| United States | GSK Investigational Site | Charleston | West Virginia |
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| United States | GSK Investigational Site | Chaska | Minnesota |
| United States | GSK Investigational Site | Chattanooga | Tennessee |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chiefland | Florida |
| United States | GSK Investigational Site | Cincinnati | Ohio |
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| United States | GSK Investigational Site | Clarksville | Tennessee |
| United States | GSK Investigational Site | Clearwater | Florida |
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| United States | GSK Investigational Site | Concord | North Carolina |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dawsonville | Georgia |
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| United States | GSK Investigational Site | Deerfield Beach | Florida |
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| United States | GSK Investigational Site | Elkhart | Indiana |
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| United States | GSK Investigational Site | Glendale | Arizona |
| United States | GSK Investigational Site | Grand Blanc | Michigan |
| United States | GSK Investigational Site | Grand Prairie | Texas |
| United States | GSK Investigational Site | Greensboro | North Carolina |
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| United States | GSK Investigational Site | Henderson | Nevada |
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| United States | GSK Investigational Site | Holly Hill | Florida |
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| United States | GSK Investigational Site | Huntsville | Alabama |
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| United States | GSK Investigational Site | Lake Success | New York |
| United States | GSK Investigational Site | Lancaster | Texas |
| United States | GSK Investigational Site | Las Vegas | Nevada |
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| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Los Gatos | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
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| United States | GSK Investigational Site | Madisonville | Kentucky |
| United States | GSK Investigational Site | Manchester | Missouri |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Meridian | Idaho |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Muscle Shoals | Alabama |
| United States | GSK Investigational Site | Nixa | Missouri |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | Northport | Alabama |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Olive Branch | Mississippi |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orange | California |
| United States | GSK Investigational Site | Oregon City | Oregon |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Ormond Beach | Florida |
| United States | GSK Investigational Site | Palm Springs | California |
| United States | GSK Investigational Site | Pasadena | Maryland |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pismo Beach | California |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Portage | Michigan |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Reading | Pennsylvania |
| United States | GSK Investigational Site | Richardson | Texas |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Rockford | Illinois |
| United States | GSK Investigational Site | Rockville | Maryland |
| United States | GSK Investigational Site | Saint Cloud | Florida |
| United States | GSK Investigational Site | Saint Louis | Missouri |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Stockbridge | Georgia |
| United States | GSK Investigational Site | Stratford | Connecticut |
| United States | GSK Investigational Site | Sun City | Arizona |
| United States | GSK Investigational Site | Suwanee | Georgia |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tempe | Arizona |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Traverse City | Michigan |
| United States | GSK Investigational Site | Trumbull | Connecticut |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Virginia Beach | Virginia |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Wellesley Hills | Massachusetts |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Woonsocket | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| Cubist Pharmaceuticals LLC | GlaxoSmithKline |
United States, Australia, Austria, Canada, Denmark, Finland, Hong Kong, Hungary, Ireland, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To compare alvimopan with placebo for long-term safety and tolerability | 12 months | ||
| Secondary | Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) | 12 months |
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